“UC Irvine Extension’s regulatory affairs courses increase our students’
value to their employers, and we support RAPS’ commitment to advancing
the careers of those in the healthcare products profession,” said Dave
Dimas, director of engineering, sciences and information technology at
UC Irvine Extension. “Students who enroll in our courses to achieve RAC
certification will have the opportunity to advance more quickly in the
healthcare products field, and will have the potential for increased
compensation.”

Regulatory
Affairs for Post-Market Approval – This online course will teach
participants about “design transfer” from research and development to
manufacturing, along with strategies of how to manage regulatory
affairs activities for design modifications, post approval studies and
after market product change. The 12 credit course will run from April
9 – May 20, 2012.

Regulatory
Requirements for Pharmaceutical Products – This online course
presents a detailed overview of the regulatory requirements for the
development and manufacture of pharmaceutical products for
participants. Attendees will learn about the product development
process through commercialization, product characterization and
pre-clinical evaluation, clinical trial requirements, along with
additional topics. The 16 credit course will run from March 26 – June
10, 2012.

Regulatory
Requirements for Medical Devices – Online course participants will
be provided with an understanding of the essential U.S. medical device
regulations, including device classification, organizing pre-market
notification 510(k), and planning and submitting a pre-market approval
(PMA). Attendees will increase their knowledge of topics that include:
global vigilance requirements and labeling requirements, European
Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments,
meeting E.U. essential requirements, and developing a technical file
for the E.U. The 16 credit course will run from March 26 – June 10,
2012.

About UC Irvine Extension:
University of California, Irvine Extension is the continuing education
arm of UC Irvine. Through thousands of courses and programs offered on
campus, online and on site, UC Irvine Extension helps adult learners
reach their career advancement and personal enrichment goals — and is
celebrating 50 years of providing universally accessible,
university-level learning to local, regional, and global communities.
Learn more at extension.uci.edu,
or join us on Facebook at facebook.com/uciextension.

About the University of California, Irvine:
Founded in 1965, UCI is a top-ranked university dedicated to research,
scholarship and community service. Led by Chancellor Michael Drake since
2005, UCI is among the most dynamic campuses in the University of
California system, with nearly 28,000 undergraduate and graduate
students, 1,100 faculty and 9,000 staff. Orange County’s largest
employer, UCI contributes an annual economic impact of $4.2 billion. For
more UCI news, visit www.today.uci.edu.